Wednesday, May 25, 2011

Fraudulent Statements for Which Tobacco Companies Were Found Guilty Under RICO Statute are Now Being Made by Tobacco Control Researchers

In a shocking development, anti-tobacco researchers - including a member of the FDA Tobacco Products Scientific Advisory Committee (TPSAC) - are today telling the public that a particular brand of Marlboro cigarettes (Marlboro Virginia blend) is safer than many other brands of cigarettes on the market, including regular Marlboros, Marlboro special blend, Marlboro blend No.27, Marlboro blend No. 54, Marlboro smooth menthol, Basic, Camel, Winston, Kool, Pall Mall, Newport, and Doral.

Specifically, these tobacco control researchers are asserting that Marlboro Virginia blend cigarettes are safer than many other cigarette brands because they contain lower levels of tobacco-specific nitrosamines (TSNAs), which reduces the risk of cancer among smokers of this cigarette brand.

The researchers report that the overall level of TSNAs in Marlboro Virginia blend cigarettes is only 76 ng/cigarette, compared to 398 in Marlboro full flavor, 353 in Marlboro special blend, 371 in Marlboro blend No. 27, 572 in Marlboro blend No. 54, 386 in Marlboro smooth menthol, 514 in Basic, 301 in Camel full flavor, 424 in Winston full flavor, 327 in Kool filter kings, 279 in Pall Mall full flavor, 467 in Doral, and 340 in Newport.

Furthermore, the researchers assert that "higher levels of TSNA in cigarette smoke are associated with a higher risk of cancer in smokers."

Thus, these researchers are asserting that the lower levels of TSNA present in Marlboro Viriginia blend cigarettes are associated with a lower risk of cancer, and therefore, a safer cigarette compared to all the other brands tested in their study.

The researchers blast Philip Morris, Reynolds American, and Lorillard for failing to reduce the levels of TSNAs in their cigarettes over the past three decades, calling this failure a "remarkable neglect" by the tobacco industry.

In contrast, the researchers congratulate the Canadian cigarette manufacturers for lowering TSNA levels in their cigarettes. The researchers call on the FDA to require a reduction in TSNA levels in American-made cigarettes.

If Philip Morris were to make the exact same assertion as these tobacco control researchers, it would take all of about five minutes before the company would be attacked by anti-smoking groups for continuing its decades of fraud and deception of the public about the claim that some brands of cigarettes are safer by virtue of lower delivery of certain toxic constituents.

In fact, the major tobacco companies were found guilty of fraudulent activity under the RICO statute for making very much the same claim that these anti-tobacco researchers make today in their article: that certain brands of cigarettes are safer based on their lower delivery of specific carcinogens.

In my opinion, the assertion by these researchers, if appearing in any forum other than a research article, would be fraudulent. It would be little different from the deception of which we in tobacco control have attacked the tobacco companies.

Let's face the facts. If I were, today, to make a statement on my blog that Marlboro Virginia blend cigarettes are safer than Camel cigarettes, I would be essentially guilty of fraud. Certainly, I would be guilty of making a fraudulent claim. The claim would also be damaging, because it could mislead some smokers to believe that the cigarettes they are smoking are safer. I can assure my readers that I would not make such a claim unless I had very solid evidence to back it up.

But this is precisely the claim that these researchers are making today!

They are asserting that Marlboro Virginia blend cigarettes are safer than Camel cigarettes and a host of other brands because they deliver much lower levels of TSNAs and therefore reduce cancer risk. They are asserting that Marlboro Virginia blend cigarettes are less carcinogenic than other brands of cigarettes. They are also asserting that Canadian cigarettes are generally safer than U.S. cigarettes.

This is a first, as far as I am aware. I have never before witnessed anti-smoking researchers or advocates claim that one brand of tobacco cigarettes on the market is any safer than another brand.

Ironically, Philip Morris has had the restraint to refrain from honestly and accurately telling consumers of its Marlboro Virginia blend cigarettes that: "In the opinion of some anti-smoking researchers, this is a safer cigarette because it reduces your risk of cancer."

The glaring flaw in the reasoning of this study is that TSNAs are only one of the many (more than 60) carcinogens in tobacco smoke, and it is not necessarily the case that reducing TSNAs will reduce overall cancer risk. For example, it is entirely possible that the process of reducing TSNAs results in an increase in the level of some other carcinogens.

In fact, there is strong evidence that this in indeed the case. One of the prime strategies for reducing TSNAs is shifting from burley to flue-cured tobacco. While this does result in lower TSNA levels, it also appears to increase levels of benzo(a)pyrene and tar. Since tar and benzo(a)pyrene are also implicated in cancer risk, it is entirely possible that reduced TSNA cigarettes could increase cancer risk. We simply do not know.

Moreover, the cigarette smoke TSNA yields were studied using a smoking machine, not a real person. It is an unwise extrapolation to assume that the yields derived by a machine are going to be the same as those produced by an actual smoker, who may increase smoking intensity (puff volume and amount smoked) in response to decreases in certain constituents in the cigarette.

Just as it would be irresponsible, fraudulent, and illegal for Philip Morris to claim that its Marlboro Virginia blend cigarettes are safer than many other cigarette brands, I believe it is also irresponsible and inaccurate for those of us in tobacco control to assert that Marlboro Virginia blend cigarettes are less carcinogenic than other brands.

The FDA would be well-advised not to follow the researchers' recommendations here because such an action would essentially amount to a shift of the fraudulent tobacco industry claim of the past that cigarettes which deliver lower amounts of some constituent are safer than other brands from Big Tobacco over to the federal government. There is simply no scientific support for such an assertion. Thus, there is no scientific support for such a regulation. I hope this type of reasoning does not make its way over to the TPSAC.

What a tragedy it would be if the FDA did require the lowering of TSNA levels, forcing tobacco companies to abandon burley tobacco and switch to other blends which - although producing lower TSNA cigarettes - also produced cigarettes with higher yields of benzo(a)pyrene and other carcinogens, resulting in an overall increase in cancer risk among the population.

Of note, the researchers in this study did not measure any other carcinogens (other than TSNAs). Thus, I don't see how they can assert that Marlboro Virginia blend cigarettes are safer.

Not only are these researchers asserting that Marlboro Virginia blend cigarettes are safer than other brands, but they are also asserting that one can compare the carcinogenicity of any two brands of cigarettes simply by examining their TSNA content. Thus, for example, they are asserting that although not as safe as Marlboro Virginia blend cigarettes, Camel No. 9 menthols are less carcinogenic than Marlboro full flavor cigarettes.

Can you imagine R.J. Reynolds displaying ads in retail stores notifying the public that: "In the opinion of anti-tobacco researchers, Camel No. 9 menthol cigarettes produce a lower cancer risk than Marlboro full flavor cigarettes. As a tobacco company, we make no such assertion. We remind the public that they should be guided by the opinions of public health professionals. We defer to the opinions expressed by these professionals."

It is surprising that the tobacco companies aren't already having a field day with these assertions in this published article.

I should add that this deception - now being practiced by tobacco control practitioners rather than by tobacco companies - is not just taking place in the U.S. It is occurring internationally, as the implementing bodies for the Framework Convention on Tobacco Control are also proposing regulations on the TSNA content of cigarettes, which could potentially lead to an increase in overall cancer risk, but at best would be a guinea pig experiment on the world population accompanied by an implied fraudulent assertion of relative safety compared to older cigarettes.

I cannot help but close this piece by speculating as to the reasons why these study authors would make such an unfounded assertion, one that if made by tobacco companies instead of anti-smoking advocates would immediately bring vicious attacks and most certainly, a rash of lawsuits.

My only speculation is that anti-smoking advocates often have so much zeal and determination to attack the tobacco companies that this zeal can obscure scientific judgment. Apparently, the underlying "purpose" of this study was to show that TSNA levels have not decreased over time and therefore, that the tobacco companies have committed some sort of irresponsible, negligent act. If you read the entire paper, you'll see that this is indeed the underlying premise of the paper.

So if you begin from a position of wanting to attack the tobacco companies, I suppose that when you indeed find that TSNA levels have not declined, your first thought is to attack the tobacco companies and accuse them of "neglect," rather than to realize that if the tobacco companies had taken your recommended action and advertised their products as safer because of lower TSNA yields, those very same companies would have been attacked by anti-smoking advocates for misleading the American people and likely, would have faced a multitude of lawsuits for fraudulent deception of consumers.

The rest of the story, then, is that in their apparent zeal to attack the tobacco companies, anti-smoking researchers have made inaccurate and unsupported scientific assertions that are damaging to the public's appreciation of the hazards of smoking and of the lack of existence of any demonstrably safer brand of tobacco cigarettes in the current market.

What is even more shocking to me, however, is that although anti-smoking researchers are apparently readily willing to assert that some cigarette brands are safer than others, they are not willing to entertain even the possibility that some non-combusted, non-tobacco products (such as electronic cigarettes) are safer than combusted tobacco products such as the ones that were investigated in this study.

ADDENDUM (May 25, 2010 - 3:30 pm): Just moments ago, the FDA released warning letters to a number of tobacco retailers, declaring them guilty of health fraud for implying that their products are safer than other tobacco products on the market. The FDA asserted that: "To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products."

In light of this clear statement by the FDA, perhaps they should also send a warning letter to the authors of this research article, since the assertions in this article represent "health fraud"according to the FDA.

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About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.